Fixing What Ails Us: Challenges in Health Care Delivery and Solutions Today March 1, 2013 QF 2013: Inspiring Improvement

Todd L. Allen MD FACEP Institute for Healthcare Delivery and Research Intermountain Healthcare Salt Lake City, Utah

Outline

The success of modern medicine

The failures of modern medicine

Our miracles fall short of their potential

Moving to a profession based practice

A brief history of QI theory

Shared baselines and accountable care

Disclosures

Neither I, Todd L. Allen, nor any

family members, have any relevant financial relationships to be discussed, directly or

indirectly, referred to or illustrated with or

without recognition within the presentation.

I have no financial relationships beyond my employment at Intermountain Healthcare.

We Live In An Age of Miracles

We Live In An Age of Miracles

We Live In An Age of Miracles

Human genome is fully available

Heart disease deaths down by 40% in a decade

Stem cell research and advancements

Minimally invasive surgical techniques

Targeted drug therapies for cancer

HIV/AIDS turned into a chronic disease

Electronic health records

Inflation

What was the price of this product in: 1972? 1978? 2012?

Alain Enthoven, PhD

Stanford University

“The United States does not have

decades to wait for health system

reform; in 2009 about $1.15 trillion of the

federal budget was spent on health

care. And health care expenditures are

growing 2.7% per year faster than non-

health care gross domestic product.

[The current] reform bill does practically

nothing to slow health expenditures.”

Reform, Part Deux

The Next Step

Health Care Reform,

as opposed to the

health insurance reform that passed (PPACA) and was upheld by the Court.

Principles for Healthcare Reform

There is no perfect healthcare system

Other systems have useful components

Simplicity in reform probably trumps complexity

Every efficient system imposes caps on spending and engages in strategic rationing

Fairness and access are fundamental principles of healthcare, but these are variously defined

Higher spending does not correlate with improved outcomes

Administrative costs and complexity in the US are comparatively high

Naylor CD. JAMA 2012; 307(9): 919

The Emergence of Modern Medicine:

1860-1910

• New high standards for clinical education • Flexner Report: more than half of all U.S. "medical schools" shut down

• New model: hospital-based 2 year course of study (integrated clinical exposure)

• Strict requirements for professional licensing

• Clinical practice founded on scientific research • Shift to germ theory, rather than "an imbalance of the 4 bodily humors,“ as

the basis for understanding disease and its treatment

• Health care's first entry into "evidence-based medicine"

• New internal organization for hospitals

Porter, R. The Greatest Benefit to Mankind: A Medical History of Humanity. New York, NY: W.W. Norton and Company; 1997.

Barry, JM. The Great Influenza: The Epic Story of the Deadliest Plague in History. New York, NY: The Penguin Group; 2004.

Starr, P. The Social Transformation of American Medicine. New York, NY: Basic Books (The Perseus Books Group; 1984.

Rosenberg, CE. The Care of Strangers: The Rise of the American Hospital System. New York, NY: Basic Books; 1987.

"... for the first time in human history, a random patient with a random disease consulting a doctor chosen at random stands a better than 50/50 chance of benefitting from the encounter."

1912 : The 'Great Divide'

Harvard Professor L. Henderson

(Harris, Richard. A Sacred Trust. New York, NY: New American Library, 1966)

"I am sorry for you, young men (and women) of this generation. You will do great things. You will have great victories, and standing on our shoulders, you will see far, but you can never have our sensations. To have lived through a revolution, to have seen a new birth of science, a new dispensation of health, reorganized medical schools, remodeled hospitals, a new outlook for humanity, is not given to every generation."

At the opening of the Phipps Clinic in England, near the end of his career.

Sir William Osler

Reid, Edith Gittings. The Great Physician: A Life of Sir William Osler. New York, NY: Oxford

University Press, 1931 (p. 241).

Current Health Care

Is the best the world has ever seen

A few simple examples:

From 1900 to 2000, average life expectancy at birth increased from only 49 years to almost 77 years.

Since 1960, age-adjusted mortality from heart disease (#1) has decreased by 56%; and (from 307.4 to 134.6 deaths / 100,000)

Since 1950, age-adjusted mortality from stroke (#3) has decreased by 70%. (from 88.8 to 26.5 deaths / 100,000)

Initial life expectancy gains almost all resulted from public health initiatives -- clean water, safe food, and (especially) widespread control of epidemic infectious disease. But since about 1960, direct disease treatment has

made increasingly large contributions.

Total health: How long, how well we live

~40%

Behavior: Tobacco

Ethanol (and other recreational drugs)

MDD (movement deficit disorder - obesity)

Sexually-transmitted disease (AIDS)

Unwed teenage pregnancy

Suicide, violence, & accidents (young men)

McGinnis JM & Foege WH. Actual causes of death in the United States. JAMA 1993; 270(18):2207-12 (Nov 10).

McGinnis JM, Williams-Russo P, & Knickman JR. The case for more active policy attention

to health promotion. Health Affairs 2002; 21(2):78-93 (Mar).

Genetics

~30%

~20%

Health care delivery (hospitals and clinics) ~10%

The Great Equation:

Health = Medical Care

"But the Great Equation is wrong ..."

Aaron Wildavsky. Doing better and feeling worse: the political pathology of health policy. Doing

Better and Feeling Worse: Health in the United States, John H. Knowles, ed. New York: W.W.

Norton & Co., 1977.

and medical care = access to care

What Do We Get For All That Money?

1. Total health -- how long and how well we live

2. High touch -- patients value their relationship with a trusted clinical advisor more than any other element in health care delivery (the clinician-patient relationship)

W. Edwards Deming: Aim defines the system ...

Three possible aims of a health care delivery system:

A man stricken with disease today is assaulted by the same fears and finds himself searching for the same helping hand as his ancestors did five or ten thousand years ago. He has been told about the clever tools of modern medicine and somewhat vaguely, he expects that by-and-by he will profit by them, but in his hour of trial his desperate want is for someone who is personally committed to him, who has taken up his cause, and who is willing to go to trouble for him.

D. Emerick Szilagyi, MD: In Defense of the Art of Medicine, 1965

(with thanks to Dr. Steven Kappes, Milwaukee, WI)

High touch: caring, not just curing

High Touch? Maybe not ...

1. Total health -- how long and how well we live

2. High touch -- patients value their relationship with a trusted clinical advisor more than any other element in health care delivery (the clinician-patient

relationship)

W. Edwards Deming: Aim defines the system ...

Three possible aims of a health care delivery system:

3. Rescue care -- the Rule of Rescue

Primary care vs. Secondary care

Rapid Response: The Rule of Rescue

• Subconscious personal identification at an emotional level; • A person instead of just a number; "a name and a face"

The child down the well

The whales trapped in the ice

The dog on the abandoned boat

"60 Minutes" program on pertussis vaccination

(who killed more than 17 million of his own Russian people)

"A single death is a tragedy, a million deaths is a statistic."

Jonsen AR, 1986: The imperative people feel to rescue identifiable individuals facing (avoidable?) suffering or death.*

* McKie J & Richardson J. The rule of rescue. Soc Sci Med 2003; 56(12):2407-19 (June).

Richardson J & McKie J. Working Paper 112: The Rule of Rescue. West Heidelberg, Victoria, Australia: The Centre for

Health Program Evaluation; 2000.

I grew up in Glasgow, Scotland,

where death was seen as imminent ...

I trained in Canada,

where death was seen as inevitable ...

I now live and work in California,

where death is seen as optional.

Ian Morrison, President, Institute for the Future (IFTF) c/o Richard Smith, editor, the British Medical Journal

Rule of Rescue - Personal Level

Current care delivery

offers opportunities ...

OR

Fixing what ails us,

episode1

(We can't solve problems using the same kind

of thinking we used when we created them)

Today's problems are often

yesterday's solutions.

Albert Einstein

(It works better if you plug it in)

He that will not apply new remedies must expect new evils; for time is the

greatest innovator.

Francis Bacon (1561 - 1626); in Essays (1625), Of Innovations

1. Well-documented, massive, variation in practices (beyond

the level where it is even remotely possible that all patients are receiving good care)

2. High rates of inappropriate care

3. Unacceptable rates of preventable care- associated patient injury and death

4. A striking inability to "do what we know works"

5. Huge amounts of waste and spiraling prices, that limit access (48.2 million uninsured Americans, and still climbing)

Care Falls Short of its Theoretic Potential

To Improve Quality

Document continuous improvement

(process steps)

(outcomes)

Eliminate inappropriate variation

Waste In Healthcare

American healthcare gets is right 54.9% of the time1

45-50+% of all resource expenditure in hospitals is quality-associated waste2

• Recovering from preventable mistakes

• Building unusable products

• Providing unnecessary treatments

• Simple inefficiency

1. McGlynn EA. The quality of healthcare delivered to adults in the United States. NEJM 2003; 348(26): 2635-45

2. James BC, Savitz L. 2006 AHRQ Report

The healing professions are

changing ...

Or

Three methods for managing care,

Fixing what ails us, episode 2

The Healing Professions are Changing

From craft-based practice

• Individual physicians, working alone

• Handcraft a customized solution for each patient

• Based on a core ethical commitment to the patient and

• Vast personal knowledge gained from training and experience

To a profession-based practice

• Groups of peers, treating similar patients in a shared setting

• Plan coordinated care delivery processes

• Which individual physicians adapt to specific patient needs

The Craft of Medicine (each physician an expert)

An individual physician

• Placing her patient’s healthcare needs before any other end or goal,

• Drawing on extensive clinical knowledge gained through formal education and experience

Can craft

• A unique diagnostic and treatment regimen customized for that particular patient

Medicine’s promise:

This approach will produce the best result possible for each patient

Quality arises from personal competence;

Thus,

Errors represent professional incompetence.

Organized Care

How could we create a system that:

1. Consistently documents "the best medical outcome at the lowest necessary cost" under each patient's full control (true "patient-centered"

care)

2. Learns from every case - generates scientifically reliable knowledge

from routine practice, quickly filling the 80-90% evidence gap regarding best practice; while

empirically validating every new treatment.

3. Creates a life-long "residency training while in practice“ - organization-level capacity to (1) identify critical new knowledge, (2) blend it into daily workflows, (3) package it for rapid learning, and (4) push it out to

all who need it - reduce the time for widespread adoption of major new scientific findings from ~17 years

to less than 6 months.

4. Generates true transparency - anytime any clinician says "in my

experience" they mean "in my measured experience." Eliminate reliance on subjective

recall; make physicians and nurses better counselors as they advise and support patients faced with treatment decisions.

5. Addresses innate clinical complexity - provide support around critical

clinical decisions (Shared Baselines)

Why a Profession-Based Practice?

1. It produces better outcomes for our patients

2. It eliminates waste, reduces costs, and increases available resources for a patient’s care

3. It puts the caring professions back in control of care delivery

4. It is the foundation for useful shared electronic data – an important next step in continuous quality improvement

Scientific Management

Developed by Frederick Taylor about 1911

Defined mass production (assembly line) methods

Time and motion studies

Based on the idea of processes

• On one side: well educated engineers who designed the processes

• On the other side: uneducated workers who did

as they were told

Transformed the world – quickly and

thoroughly supplanted craft style

production

Still in use throughout the world

Scientific Management

Fails in the face of increasing

complexity

Method 1: Data Feedback

• History in Intermountain’s QUE studies

• Use data for learning versus judgment

• Limitations of data feedback

1. Challenges balancing comorbidities and complications

2. Challenges with sample size

3. Physician profiling is methodologically unsound in a quality improvement setting

Managing Clinical Variation

Year Author/Idea

1911 Frederick Taylor: Principles of Scientific Management (mass assembly line production)

1931 Walter Shewhart: Economic Control of Quality Manufactured Product (introduced SPC techniques)

1939 Shewhart: Statistical Method from the Viewpoint of Quality Control

World War II – Wallis contacts Deming

Year Author/Idea

1951 W. Edwards Deming: Elementary Principles of the Statistical Control of Quality

1990 James Womack et al: The Machine that Changed the World

Deming’s Core Theory

• All productive activity happens through definable processes

• All processes produce three categories of parallel outcomes

- Physical, cost and service outcomes

• All processes contain built-in variation (called “common cause” variation

• All processes are also affected by external factors (called “special cause” variation)

• Quality controls cost

• Common variation can be modified or controlled through good system design

Lean or Pull-Through Production

Standardized processes with

Smart cogs that

Adapt to individual needs

That is, “MASS CUSTOMIZATION”

(efficient process that can deal with complexity)

Methods to Manage Complexity

Subspecialize (analytic method; reductionism; 'divide and conquer') (old joke: Know more and more about less and less

until you know everything about nothing)

Mass customize (a shared baseline: focus on that relatively small subset of factors that are unique by and for each individual patient [typically 5-15%], concentrating your most important resource -- the trained human mind -- where it can have the greatest impact)

Clinical Uncertainty (a hundred years of science)

Enthusiasm for unproven methods ... Mark Chassin, MD

The maxim, "If it might work, try it" ... David Eddy, MD, PhD

Quality means "spare no expense" ... Brent James, MD, MStat

1. Lack of valid clinical knowledge regarding best treatment (poor evidence)

2. Exponentially increasing new medical knowledge doubling time has decreased to ~8 years; at current rates, a clinician will need to learn, unlearn, then

relearn half of their medical knowledge base 5 times during a typical career

3. Continued reliance on subjective judgment (subjective recall is

dominated by anecdotes, and notoriously poor when estimating results across groups or over time)

4. Limitations of the expert mind when making complex decisions

Miller, 1956: The magic number 7, plus or minus 2: some limits on our capacity for processing information

Eddy: "The complexity of modern medicine exceeds the capacity of the unaided human mind"

Which, combined with the craft of medicine, leads to:

Until now, we have believed that the best way to

transmit knowledge from its source to its use in

patient care is to first load the knowledge into

human minds … and then expect those minds, at

great expense, to apply the knowledge to those

who need it. However, there are enormous ‘voltage

drops' along this transmission line for medical

knowledge.

Lawrence L. Weed

Weed LL. New connections between medical knowledge and patient care. BMJ 1997; 315(7102):231-5 (Jul 26).

"Our minds are interpreters of evidence. We can accurately convert all forms of evidence (formal evidence, observations, experiences, colleague's experiences) into conclusions, which in turn determine our actions."

The Core Assumption

"Therefore, no one has to tell us what to do. Just give us the evidence and we will figure it out. Besides, there are lots of other factors that need to be considered. This can only be done with clinical judgment."

Evidence Our

minds Conclusions Actions

Dr. David Eddy

• Poor evidence for most practices

• The inherent complexity of modern medicine, versus the limitations of the human mind

Lead to

• Huge variations in beliefs

• Well-documented, massive, variations in practices

• High rates of inappropriate care

• Unacceptable rates of preventable patient injury

• A striking inability to "do what we know works"

• Wasted resources on a large scale (= decreased access to care)

The Core Assumption is Untenable

Dr. David Eddy

Other Factors Affect Our Decisions

Evidence Our

minds Conclusions Actions

Dr. David Eddy

Professional interests

Financial interests

Clinician preferences and personal tastes

Desire to have something to offer (Rule of Rescue)

Love for the work

Wishful thinking

Selective memory

Pressure from patients and family (direct to consumer advertising)

Legal considerations (defensive medicine)

If our minds can't do the work very well, there are all sorts of other things to fill the void:

Huge ranges of uncertainty Limited, complex Massive variation, inappropriate care

Method 2: Practice Protocols

1. There is insufficient evidence base for most treatment choices

2. Expert medical opinion is essential random

3. Practice guidelines do not often change practice

4. Most guidelines lack sufficient specificity to actually guide practice

5. Most guidelines have no validation data

We Have Found Proven Solutions

Shared Baselines (a form of Lean Production)

• Select a high priority care process

• Generate an evidence based “best practice” guideline

• Blend the guideline into the flow of clinical work

• Training, staffing, supplies, physical layout, educational materials, measurement and information flow

• Use the guideline as a shared baseline with clinicians free to vary based on individual patient needs

• Measure, learn from, and (over time) eliminate variation arising from professionals, but retain variation arising from patients (mass customization)

The Principles Of Shared Baselines (or we have found proven solutions)

• Select a high priority care process

• Generate an evidence-based best practice guideline

• Blend the guideline into the flow of clinical work

• Use the guideline as a shared baseline with clinicians free to vary based on individual patient needs

• Measure, learn from and (over time)

• Eliminate (smooth out) variation arising from the professional

and retain variation arising from patients

• This is the “mass customization”

Staffing Training Supplies

Physical layout Education materials

Measurement and feedback

The Setting is Critical

• Real cases -- not abstract discussion

• Single decisions intellectually approachable can bring special methods to bear: lit review, experts, etc.

• A group of clinical peers who see similar patients in the same environment learning together, and holding each other accountable

Only Three Choices

• Decide the protocol is wrong and change it on the spot

• Decide the protocol is right -- a normative message from one's peers

• Decide that it is random noise -- while the care was appropriate and the protocol didn't cover it, it represents a rare event that would add unnecessary complexity to the protocol

Practical Limitations on Protocol Use

When abstract guidelines hit real patient care, experience clearly shows that (with very rare exception)

No protocol fits every patient;

more important,

No protocol (perfectly) fits any patient.

Physicians

It is more important that you do it the same

than that you do it “right.”

“Truth is found more often from mistakes than from confusion ...”

Francis Bacon (1561-1626)

When you “do it the same:” • Error rates fall – less complexity = fewer mistakes =

better outcomes

• Costs fall – staff is more efficient; you are more

efficient

• You can apply the scientific method to systematically improve – regardless of where you

start you will end up with demonstrated care practices.

Professional Accountability

We will not tell you how to practice medicine

• We will argue the science, but if we cannot convince physicians "on the data," we will not expect them to change how they manage patients.

We will create an environment of professional accountability

• Where groups of physicians and other professionals;

• who manage similar patients in similar settings;

• discuss best patient care practices;

• with recourse to the medical literature, expert opinion, and credible data showing their own performance and outcomes.

(A redefinition of traditional peer review)

Traditional Quality Assurance

worse better worse better Quality Quality

threshold

Before After

Quality Improvement

worse better worse better Quality Quality

Before After

The Healing Professions

• We police our own ranks -- acting on behalf of patients,

we assure that all members of the healing profession respect our fiduciary trust and are competent (a social contract; the 'official'

definition of "professional autonomy")

• We maintain a special body of knowledge -- as

clinicians, (1) We practice - we apply knowledge not generally available outside of the professions (information disparity). (2) We teach - we transmit that knowledge to the next generation. And (3) We learn - we improve the knowledge we ourselves received.

(e.g., Geisinger Health System mission: Heal. Teach. Discover. Serve.)

• We put our patients first -- as clinicians, we place our

patients' health needs before any other end or goal; we act as our patients' advocates. We accept, promote, and honor a fiduciary trust on behalf of our patients.

Realized Clinical Integration

• You must assume that front-line clinicians are

• As smart as you are

• As dedicated to patients as you are

• As hard working as you are

• As motivated as you are

• Are the ones with the fundamental knowledge of how the system actually works

• But they do not control the system that houses

the context of their work

• How will our efforts MAKE IT EASIER FOR

THEM TO DO IT RIGHT?

The 5 Axioms of Intermountain Healthcare

Most treatments for a specific condition have similar characteristics

There is still massive variation in clinician’s practices

All have something to learn and something to teach

Clinicians will lead most changes themselves

Clinical integration is our strategic plan

"I am sorry for you, young men (and women) of this generation. You will do great things. You will have great victories, and standing on our shoulders, you will see far, but you can never have our sensations. To have lived through a revolution, to have seen a new birth of science, a new dispensation of health, reorganized medical schools, remodeled hospitals, a new outlook for humanity, is not given to every generation."

At the opening of the Phipps Clinic in England, near the end of his career.

Sir William Osler

Reid, Edith Gittings. The Great Physician: A Life of Sir William Osler. New York, NY: Oxford

University Press, 1931 (p. 241).

Better has no limit ...

an old Yiddish proverb